Sanderling Dialysis Center of Holdenville

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 34696 Based on observation and interview, the facility failed to maintain and provide dialysis patients, staff, and visitors a physical environment that was safe and free of defects and hazards in four of four areas (Lobby, Storage/Machine Repair area, Water Treatment area, and Hemodialysis Treatment area). Findings included: ~ The facility failed to maintain the building to ensure all systems were functional and provided dialysis patients, staff, and the public, a safe and functional environment in one of one area (Lobby). Cross refer to V401. ~ The facility failed to maintain the building free from defects and/or hazards in three of three areas (Lobby, Storage/Machine Repair area, Water Treatment area). Cross refer to V402. ~ The facility failed to maintain the equipment in three of three areas (Storage/Machine Repair area, Water Treatment area, and Hemodialysis Treatment area). Cross refer to V403. ~ The facility failed to ensure one of one patient (Patient #1) was in view during the hemodialysis treatment. Cross refer to V407.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 34696 Based on observations, record review, and interview, the medical director did not demonstrate responsibility to ensure: 1) 1 physical environment was safe for patients, staff, and visitors, and 2) prescribed care and/or necessary services was provided to all patients, and visitors. Findings included: ~ The facility failed to maintain and provide dialysis patients, staff, and visitors a physical environment that was safe and free of defects and hazards in four of four areas (Lobby, Storage/Machine Repair area, Water Treatment area, and Hemodialysis Treatment area). Cross refer to V400. ~ The Interdisciplinary Team (IDT) failed to ensure four of four patients (Patients #5, #6, #7, and #8) had a comprehensive assessment of their needs. Cross refer to V500. ~ The Interdisciplinary Team (IDT) failed to develop and implement the plans of care for four of four patients (Patients #5, #6, #7, and #8). Cross refer to V540.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 34696 Based on observation and interview, the facility failed to ensure one of one Registered Nurse (RN, Personnel #8) wore appropriate personal protective equipment (PPE) during patient care or touching equipment. Findings included: A review of the “Personal Protective Equipment” policy dated 11/12/2012 showed, “Staff must use PPE when performing any procedure/activity where exposure to blood or other potentially infectious body fluids/infectious diseases is anticipated...Fluid resistant gown...are waterproof and protect skin and/or clothing against exposure to biological materials including body fluids...Gloves...routine exam...worn when anticipate hand contact with blood or potentially infectious materials... vascular access procedures...and when handling contaminated items or surfaces.” On 05/05/2025 during observation of care in the Hemodialysis Treatment area, the following was observed: ~ At 10:08 AM, Patient #2 was observed dialyzing at station #8. The Registered Nurse (RN, Personnel #8) was observed at Patient #2’s dialysis machine. Thee RN had his right bare hand resting on the machine, and a pair of gloves in his bare left hand. It was observed that the dialysis machine had an attached keyboard. At 10:10 AM, the RN was asked if he have gloves on when touching the patent’s equipment He replied, “I was entering information. ~ At 10:15 AM, Patient #3 was observed at station #13. The RN (Personnel #8) was observed initiating Patient #3’s dialysis treatment via catheter. The RN did not have a gown on. At 10:17 AM, the RN was asked if he was supposed to have a gown on when initiating a patient’s treatment. The RN said he did not know. On 05/05/2025 at 10:20 AM, the Nurse Manager (Personnel #1) said all staff should wear PPE when initiating or terminating a patient’s treatment or touching contaminated equipment.”

“ENVIRONMENT-SCHEMATIC DIAGRAMS/LABELS CFR(s): 494.40(a) 8 Environment: schematic diagrams/labels Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow. If water system manufacturers have not done so, users should label major water system components in a manner that not only identifies a device but also describes its function, how performance is verified, and what actions to take in the event performance is not within an acceptable range. This Standard is not met as evidenced by: 34696 Based on observation and interview, the facilty failed to identify all components in the water treatment system in one of one area (Water Treatment area). Findings included: On 05/05/2025, during a tour of the facility, the following was observed: ~ At 9:36 AM, observation showed two tanks sat in front of the multimedia and carbon filtration tanks. The tanks were not labeled to identify the name and the function of the tanks. At the time of the finding, the Nurse Manager (Personnel #1) said the tanks wee scavenger tanks. On 05/05/2025 at 9:37 AM, the Nurse Manager (Personnel #1) said the tanks had been at the facility for about three months. She said the tanks were not labeled.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 34696 Based on observation and interview, the facility failed to maintain the building to ensure all systems were functional and provided dialysis patients, staff, and the public, a safe and functional environment in one of one area (Lobby). Findings included: A review of the “Disposal of Needles and Sharps” policy dated 11/12/2012 showed, “Staff are responsible to visibly monitor sharps containers to ensure they are not more thatn 3/4 full.” On 05/05/2025 at 8:40 AM, Patient #1 was observed trying to open the main outer door of the building. The patient was observed struggling to hold her walker and open the door. Patient #1 pressed the button that automatically opens the door. It did not work. At 8:45 AM, it was observed that a secondary outer door that led into the facility’s lobby was propped open with a rubber wedge. At 8:45 AM, Patient #1 proceeded through a thrid door that led into the hemodialysis treatment area. The door had a keypad that was not engaged. This allowed unauthorized individuals to enter the treatment area without inspection. On 05/05/2025 at 9:25 AM, the Nurse Manager (Personnel #1) said the main outer door had been repaired but had stopped working. The Nurse Manager said they were not sure why the secondary door was propped open. Personnel 1 said the door that led into the treatment area does not close properly unless a staff member walks over and pulls it shut. ~ At 10:05 AM, it wa observed that the sharps container at station #12 was more than 3/4 full. On 05/05/2025 at 10:10 AM, the Nurse Manager (Personnel #1) said the sharps container should have been discarded.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 34696 Based on observation and interview, the facility failed to maintain the building free from defects and/or hazards in three of three areas (Lobby, Storage/Machine Repair area, Water Treatment area). Findings included: On 05/05/2025, during a tour of the facility the following was observed: ~ At 9:25 AM, rust was observed on the floor in the Lobby underneath the door leading into the hemodialysis treatment area. On 05/05/2025 at 9:25 AM, the Nurse Manager (Personnel #1) said the door would drag the floor. This left the rusty semi-circle on the tiled floor underneath the door. ~ At 9:30 AM, it was observed that the floor in the Storage/Machine Repair area had not been maintained. The floor was dirty and gritty throughout the area. The floor was covered with stains, tire tracks, and dried tile glue. ~ At 9:40 AM, it was further observed that the floor in the Water Treatment area had not been maintained. The floor was dirty and gritty. throughout the area. There was dirt and debris in the corners of the room. The cement floor underneath and in front of the 2.0 potassium (K+) and 2.5 calcium (Ca) acid tank was discolored black and white. There was a one to two inch tall mound of crystallized acid on the floor underneath the tanks drain spout. The floor had approximately ten feet by two feet of corrosion. The facility’s two water heaters sat atop a circle of rust on the floor. ~ At 9:55 AM, the restroom available for patient use in the Hemodialysis Treatment area had no way for patients to call for help. The pull cord in the restroom did not work. The alarm and the light over the restroom door did not work. ~ At 10:30 AM, it was observed that each dialysis machine had drain hoses that fed into a wall box with a drain. It was observed that the wall boxes behind the dialysis machines at each station (there are 16 hemodialysis stations) had a yellowish substance that sat in the box around the drain. On 05/05/2025 at 10:55 AM, the Certified Clinical Hemodialysis Technician (CCHT)/facility Biomed (Personnel #3) the staff never clean the wall boxes. On 05/06/2025 at 8:30 AM, the restroom available for patient use in the Lobby had no way for patients to call for help. The pull cord in the restroom did not work. There was no light over the restroom door. The restroom had not been maintained. The tiled floor was dirty and faded. The restroom had a strong smell of sewage. On 05/06/2025 at 8:35 AM, the Nurse Manager said the restroom had not been maintained. On 05/07/2025 at 8:40 AM, the Senior Biomed (Personnel #6) said the last time he was at the facility was a year ago. The Senior Biomed said he was there to repair dialysis machines. He did not look at the Water Treatment area.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 34696 Based on observation and interview, the facility failed to maintain all equipment in three of three areas (Storage/Machine Repair area, Water Treatment area, and Hemodialysis Treatment area). Findings included: On 05/05/2025 during a tour of the facility, the following was observed: ~ At 9:32 AM, hemodialysis machines #207 and #221 were observed in the Machine Repair area. The machines were not labeled to indicate if the machines were ready to use or if they were in disrepair. On 05/05/2025 at 9:35 AM, the Nurse Manager (Personnel #1) said the machines were from Chicago and had not been put circulation. On 05/05/2025 at 11:10 AM, the Certified Clinical Hemodialysis Technician/ facility Biomed (Personnel #3) said the dialysis machines were not labeled. ~ At 9:36 AM, water was observed on the floor around two unlabeled tanks in front of the multimedia and carbon filtration tanks. At the time of the findings, the Nurse Manager said the water had been on the floor for a week. They said the they were supposed to report problems to the senior Biomed. On 05/07/2025 at 8:40 AM, the Senior Biomed (Personnel #6) said the water around the tanks was coming from the filter on the back of the reverse osmosis (RO) machine. They said the wrench available to tighten the filter did not fit properly. ~ At 10:25 AM, it was observed that the Automated External Defibrillator (AED) was not maintained. The Nurse Manager opened the AED. The defibrillator pads for the AED expired 06/10/2023. The Nurse Manager opened the AED to test and said they could use their finger to turn the machine on. The Nurse Manager used the tip of an ink pen to turn the machine on. The Nurse Manager attempted to turn the machine on a second time. The machine would not turn on. ~ At 2:00 PM, the treatment chairs at stations #7 and #12 could not be effectively cleaned. The chairs had rips and tears in the armrests. On 05/05/2023 at 2:20 PM, the Nurse Manager said the chairs had tears and could not be effectively cleaned.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 34696 Based on observation and interview, the facility failed to ensure one of one patient (Patient #1) was in view during the hemodialysis treatment. Findings included: On 05/05/2025 at 10:00 AM, Patient #1 was observed dialyzing at station #1. The patient’s face was not visible. Patient #1’s face was covered with the hood from their jacket. On 05/05/2025 at 10:05 AM, the Certified Clinical Hemodialysis Technician (CCHT, Personnel #2) said Patient #1’s face should not be covered. On 05/05/2025 at 10:05 AM, the Nurse Manager (Personnel #1) said the facility did not have a policy for covered faces during treatment.”

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 34696 Based on record review and interview, the facility failed to ensure the Registered Nurse (RN) and the attending Physician provided four of four patients (Patients #5, #6, #7, and #8) with an individualized and comprehensive assessment as part of the Interdisciplinary Team (IDT). Findings included: A review of the “Performance of IDT and Plans of Care” policy dated 01/18/2016 indicated, “The IDT members shall include...a Registered Nurse...a Social Worker...a Registered Dietitian...a Nephrologist...Each patient will receive an evaluation by each member of the IDT.” ~ Patient #5: The medical record did not include documented evidence that the RN and Physician conducted an initial comprehensive assessment of Patient #5 in 08/2024. ~ Patient #6: The medical record did not include documented evidence that the RN and Physician conducted an annual comprehensive reassessment of Patient #6 in 01/2025. ~ Patient #7: The medical record did not include documented evidence that the RN and Physician conducted an annual comprehensive reassessment of Patient #7 in 10/2024. ~ Patient #8: The medical record did not include documented evidence that the RN and Physician conducted an initial comprehensive assessment of Patient #8 in 04/2025. On 05/06/2025 at 3:30 PM, the Nurse Manager (Personnel #1) said the comprehensive assessment or reassessments for Patients #5, #6, #7, and #8 were not conducted by the RN and Physician.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 34696 Based on record review and interview, the Interdisciplinary Team (IDT) failed to develop and implement a complete comprehensive plan of care for four of four patients (Patients #5, #6, #7, and #8). Findings included: ~ Patient #5: The medical record did not include documented evidence that the RN and Physician participated in the development of an initial plan of care for Patient #5 in 08/2024. ~ Patient #6: The medical record did not include documented evidence that the RN and Physician participated in the development of an annual plan of care for Patient #6 in 01/2025. ~ Patient #7: The medical record did not include documented evidence that the RN and Physician participated in the development of an annual plan of care for Patient #7 in 10/2024. ~ Patient #8: The medical record did not include documented evidence that the RN and Physician participated in the development of an initial plan of care for Patient #8 in 04/2025. On 05/06/2025 at 3:30 PM, the Nurse Manager (Personnel #1) said thee RN and Physician parts of the plans of care for Patients #5, #6, #7, and #8 were not developed.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 34696 Based on record review and interview, the facility failed to ensure staff demonstrated the competencies necessary to serve collectively the comprehensive needs of the patients, citing one of one staff (Personnel #3 and #8) who did not have documented evidence that they demonstrated the skill required to be a Biomed or direct patient care staff. Findings included: ~ The training records of the facility Biomed (Personnel #3) did not have documented evidence that they demonstrated the skill to perform preventive maintenance on the dialysis machines and the water treatment system. On 05/07/2025 at 9:30 AM, the Senior Biomed (Personnel #6) said Personnel #3 had been a Biomed at the facility since 2019. The Senior Biomed said they had not performed Personnel #3’s annual biomed training since 2021. ~ The training records of the Registered Nurse (RN, Personnel #8) did not have documented evidence that they demonstrated the competency to provide Hemodialysis care. (The RN was observed providing care during observation of care on 05/05/2025.) On 05/07/2025 at 3:30 PM, the Nurse Manager (Personnel #1) said the RN did not have documented evidence of competencies for hemodialysis at the time of observation of care. They said the RN had worked at the facility “for a couple of months.””